K082314 is an FDA 510(k) clearance for the BRAVORACER PEDIATRIC MANUAL WHEELCHAIR. This device is classified as a Wheelchair, Mechanical (Class I - General Controls, product code IOR).
Submitted by Otto Bock Healthcare LP (St Paul, US). The FDA issued a Cleared decision on October 28, 2008, 76 days after receiving the submission on August 13, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850. A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets mobility To Persons Restricted To A Sitting Position To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility..
| 510(k) Number | K082314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2008 |
| Decision Date | October 28, 2008 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IOR - Wheelchair, Mechanical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |
| Definition | A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets mobility To Persons Restricted To A Sitting Position To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility. |